Microbiologist I/II Quality Control Microbiology
Location
Gaithersburg, MD | United States
Job description
Microbiologist I/II Quality Control Microbiology
This position is located at the BioNTech Gaithersburg, Maryland, GMP manufacturing site. The Gaithersburg site includes functions supporting cell and gene therapy research, development, and GMP manufacturing operations. These collective functions result in a collaborative environment that is aligned from drug discovery to GMP release of drug product for our patients.
The QC Microbiologist I / II (as experience allows) is responsible for partnering with managers and subject matter experts in leading, supporting, and maintaining QC microbiological functions and contamination control for new and existing GMP manufacturing operations.
Primary responsibilities include:
- Support facility qualification operations for new GMP manufacturing areas, including Environmental Monitoring Performance Qualification (EMPQ) and GMP utilities qualification.
- Perform environmental monitoring (EM) of GMP classified cleanrooms.
- Perform sampling and testing of GMP utilities, including purified water and clean gases.
- Perform microbiological assays and operations such as Rapid Sterility, Rapid Endotoxin, Gram Stain, Microbial Identification, Growth Promotion, Bioburden, and plate reading.
- Review QC raw data, such as testing and logbooks.
- Support data management requirements for the team, including data entry and data verification, trending of data, and authoring of trend reports, utilizing Excel, LIMS, or other trending software.
- Perform routine maintenance of lab equipment and lab spaces.
- Conduct investigations for procedural deviations, out of specifications (OOS), and environmental monitoring / clean utility excursions. Determine and execute corrective and preventative actions (CAPA) as determined for investigations, excursions, and OOS.
- Support QC equipment qualification, including implementation of new rapid QC methods.
- Perform method qualification to support of sterility and endotoxin testing.
- Develop, revise and review SOP’s.
- Identify, author, and review change controls for the QC team.
- Lead and support continuous improvement projects such as rapid testing technology, automated testing technology, technical QC studies, LEAN, and 5S.
Requirements: - Bachelor’s or Master’s degree in the sciences and
- QC Microbiologist I: 0-2 years of experience in a GMP lab setting, preferably in a QC Microbiology lab setting, or suitable coursework in Microbiology.
- QC Microbiologist II: 2-4 years of experience in a GMP QC Microbiology lab setting.
- Experience using micropipettes for aseptic fluid transfers.
- Experience with safe lab practices and handling of biological material.
- Experience in aseptic technique and behaviors, such as those required for GMP gowning and in GMP clean rooms.
- Excellent interpersonal, verbal and written communication skills.
- Ability to organize workload and work independently and collaborate within teams, as needed, for timely completion of objectives.
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
- Ability to lift 25 lbs.
- Proficient in MS Word, Excel, and Power Point.
Preferred Requirements:
- Knowledge of GMPs, GDPs, and Quality Control processes within a QC Microbiology laboratory.
- Experience in leading and/or participating in performance qualification for environment (i.e. EMPQ) and utility qualifications.
- Experience in conducting environmental monitoring and/or GMP utility investigations that resulted in assignable root cause and effective CAPA.
- Experience in conducting risk assessments to support QC operations.
- Knowledge in pharmacopoeia and regulatory requirements related to GMP QC testing.
- Experience regulatory contamination control requirements.
- Proven ability to lead cross-functional projects from initiation to completion.
#LI-EJ1
Benefits for you:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match – could be convinced to use the word “competitive.”
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance (consolidate)
…and more! More details to be shared.
Have we kindled your pioneering spirit?
Then apply now for our location Gaithersburg and simply send us your application documents using our online form.
* BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
Job tags
Salary
